Evaxion Reveals Encouraging First Results From the Phase II Clinical Trial of Its Personalized Cancer Vaccine EVX-01
Thursday, November 02, 2023
Evaxion Biotech A/S (NASDAQ: EVAX), hereinafter “Evaxion” or “the Company”, a clinical research-focused biotechnology company specializing in the development of vaccines based on its AI immunology platform, AI-Immunology ™ is proud to announce the first results of the phase II clinical trial of its vaccine EVX-01, in line with the positive conclusions of the phase I. The Company will present a full clinical report at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (“SITC”), which will be held in San Diego, California, November 1-5, 2023.
Highlights of the initial Phase II results observed in the first five metastatic melanoma patients treated with EVX-01 include:
- Phase II data confirms the favorable safety profile observed in the Phase I trial
- Promising results of immunological and clinical tests are consistent with those of phase I
- Consistent and pronounced tumor reduction was observed with EVX-01 treatment in a patient with progressive disease
- Phase II Data Confirms the Ability of Evaxion's AI Immunology Platform, AI-Immunology ™ , to Identify Relevant Therapeutic Targets for Cancer Vaccines
Christian Kanstrup, CEO of Evaxion, said: “We strongly believe that our AI immunology platform, AI-Immunology ™ , can revolutionize the field of oncology and infectious diseases. Today's announcement highlights its potential in immuno-oncology. Our EVX-01 vaccine safely achieves robust immune responses in all patients. More particularly, the pronounced tumor reduction observed in a patient suffering from an initial progressive form of metastatic melanoma following treatment with EVX-01 represents a breath of hope for all patients suffering from a potentially fatal form of cancer. We look forward to discussing these results with potential partners.”
Join us at the SITC meeting and see our poster: “Effects of EVX-01, a personalized AI-generated neopeptide immunotherapy, in combination with pembrolizumab in patients with metastatic melanoma.” New Clinical Report,” which will be presented on November 4 between 9 a.m. and 8:30 p.m. Pacific Time.
Also, don't miss the full presentation of the phase II clinical results of EVX-01, organized in the form of an online webinar with the assistance of principal investigator, Professor Adnan Khattak, on November 8 at 11:30 a.m. , Eastern Time. To register for the event, please follow this link .
Earlier this year, Evaxion reported a successful Phase I clinical trial of EVX-01 in combination with a checkpoint inhibitor. The trial demonstrated a clinical response rate measured at 67%, in compliance with safety standards and only associated with mild adverse effects. Finally, higher quality neoantigens predicted by AI-Immunology ™ were associated with longer progression-free survival. To learn more, go here .
About the EVX-01 Phase II Clinical Trial
EVX-01 is Evaxion's lead clinical asset and is a personalized peptide-based cancer vaccine. The Phase II clinical study is a self-funded, open-label, multicenter trial conducted in collaboration with Merck Sharp & Dohme LLC, as well as leading investigators and research centers in Italy and Australia. It aims to evaluate the effectiveness and safety of use of the EVX-01 vaccine in combination with an anti-PD-1 treatment (pembrolizumab) in patients naïve to any other treatment and suffering from metastatic or non-metastatic malignant melanoma. resectable stage 3 or 4. Further information is available under clinical trial ID NCT05309421 .
About EVAXION
Evaxion Biotech A/S is a pioneering biotechnology company driven by its artificial intelligence platform: AI-Immunology ™ . Evaxion's proprietary and scalable AI predictions harness the potential of artificial intelligence to decode the human immune system and develop new immunotherapies for cancer, bacterial diseases and viral infections. Thanks to AI-immunology ™ , Evaxion has developed a clinical stage pipeline in the field of oncology with new personalized vaccines, and a preclinical stage pipeline in the field of infectious, bacterial and viral diseases, which face many unmet medical needs. Evaxion is committed to transforming patients' lives by offering them innovative and targeted therapeutic options. For more information on Evaxion and its AI-Immunology ™ platform as well as its vaccine pipeline, visit our website .
Forward-looking statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Exchange Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “target”, “believe”, “expect”, “hope”, “aim”, “intend”, “may”, “could”, “anticipate”, “consider”, “ continue”, “estimate”, “forecast”, “potential”, “predict”, “project”, “will”, “may have”, “likely”, “should”, “would”, “could” and words and Terms of similar meaning characterize forward-looking statements. Actual results may differ materially from those indicated in these forward-looking statements as a result of various factors, including, but not limited to, risks relating to: our financial condition and additional capital requirements; our development work; the cost and success of our product development and preclinical and clinical testing activities; the commercialization of any approved pharmaceutical product developed using our AI platform technology, including the rate and degree of market acceptance of our product candidates; our dependence on third parties, including for the conduct of clinical trials and manufacturing of products; our inability to enter into partnerships; government regulations; protection of our intellectual property rights; employee issues and growth management; our ADSs and ordinary shares; the impact of international economic, political, legal, regulatory, social and commercial factors, including inflation, and the effects on our business of the global COVID-19 pandemic as well as ongoing conflicts in the regions surrounding Ukraine, Russia and the Middle East; and other uncertainties affecting our business operations and financial condition. To further discuss these risks, please refer to the risk factors included in our most recent Annual Report on Form 20-F, as well as other documents filed with the Securities and Exchange Commission (SEC), available at the address www.sec.gov . We undertake no obligation to update any forward-looking statements, except as required by law.
Source: globenewswire.com
